Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals. (March 2016)

• Record Type: Journal Article
• Authors: Alépée, N.; Leblanc, V.; Adriaens, E.; Grandidier, M.H.; Lelièvre, D.; Meloni, M.; Nardelli, L.; Roper, C.S.; Santirocco, E.; Toner, F.; Van Rompay, A.; Vinall, J.; Cotovio, J.
• Is Part Of: Toxicology in vitro. Volume 31(2016)
• Page Start: 43
• Page End: 53
• Publication Date: 2016-03
• Subjects: BCOP Bovine Corneal Opacity and Permeability -- BLR between laboratory reproducibility -- C classified -- CAS RN Chemical Abstracts Service Registry Number -- Cat 1 UN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat 2 UN GHS classification for chemicals causing reversible effects on the eye/eye irritation, sub-categorised in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mildly irritant to eyes, eye effects fully reversible within 7 days of observation) -- CI confidence interval -- CM Cytosensor Microphysiometer -- CO corneal opacity -- CRL Charles River Laboratories -- EIT Eye Irritation Test -- EITL Eye Irritation Testing of Liquids -- ESAC ECVAM Scientific Advisory Committee -- EURL ECVAM European Union Reference Laboratory for Alternatives to Animal Testing -- HCE Human Corneal Epithelium -- ICCVAM Interagency Coordinating Committee on the Validation of Alternative Methods -- ICE Isolated Chicken Eye -- LO L'Oréal -- NgC negative control -- NC not classified -- NICEATM National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods -- No Cat chemicals not classified for serious eye damage/eye irritation under UN GHS/EU CLP -- NSC Non Specific Colour -- NSCliving Non Specific Colour on living tissues -- NSCkilled Non Specific Colour on killed tissues -- NSMTT non-specific reduction of MTT -- MTT 3-[4, 5-dimethylthiazole-2-yl] 2, 5-diphenyltetrazolium bromide -- OD optical density -- OECD Organisation for Economic Co-operation and Development -- PC positive control -- PBS phosphate-buffered saline -- RhCE Reconstructed human Cornea-like Epithelium -- STE Short-Time Exposure -- S.O.P. standard operating procedure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals -- VITO Flemish Institute for Technological Research -- VMG Validation Management Group -- VRM validation reference method -- WLR within laboratory reproducibility; Inter-laboratory validation -- SkinEthic HCE -- Reproducibility -- Performance -- Serious eye damage-irritation -- UN GHS Classification and Labelling of Chemicals; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2015.11.012
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: A prospective multicentric study of the reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted to evaluate its usefulness to identify chemicals as either not classified for serious eye damage/eye irritation (No Cat.) or as classified (Cat. 1/Cat. 2) within UN GHS. The aim of this study was to demonstrate the transferability and reproducibility of the SkinEthic™ HCE EITL protocol for liquids and define its predictive capacity. Briefly, 60 chemicals were three times tested (double blinded) in 3 laboratories and 45 additional chemicals were tested three times in one laboratory. Good within laboratory reproducibility was achieved of at least 88.3% (53/60) and 92.4% (97/105) for the extended data set. Furthermore, the overall concordance between the laboratories was 93.3% (56/60). The accuracy of the SkinEthic™ HCE EITL for the extended dataset, based on bootstrap resampling, was 84.4% (95% CI: 81.9% to 87.6%) with a sensitivity of 99.0% (95% CI: 96.4% to 100%) and specificity of 68.5% (95% CI: 64.0% to 74.0%), thereby meeting all acceptance criteria for predictive capacity. This efficient transferable and reproducible assay is a promising tool to be integrated within a battery of assays to perform an eye irritation risk assessment. Highlights: SkinEthic™ HCE method has been developed for the Eye Irritation Testing of Liquids. A validation study has been conducted with three laboratories on 60 substances. Good within laboratory reproducibility was achieved of at least 88.3% (53/60). The overall concordance between the laboratories was 93.3% (56/60). The accuracy was 84.4% with a sensitivity of 99.0% and specificity of 68.5% on 105 chemicals.